Immunodiagnostics Market Size, Share, Trends, Growth, and Forecasts for 2025 - 2032

Immunodiagnostics Market Size and Trends

The immunodiagnostics market size is likely to be valued at US$ 23.4 Bn in 2025 and is estimated to reach US$ 38.1 Bn in 2032, growing at a CAGR of 7.2% during the forecast period 2025-2032. Immunodiagnostics has emerged as a key segment in the clinical diagnostics market, delivering high-sensitivity and quick detection of disease-specific biomarkers. The field is witnessing rising investments due to increasing demand for early disease identification, personalized treatment options, and decentralized testing models. Immunodiagnostic platforms are playing a key role in transforming diagnostic strategies for both public health systems and private healthcare networks. As global health priorities shift toward preventive care, immunodiagnostics is increasingly positioned as a core revenue stream for diagnostics firms.

Key Industry Highlights

• Rising prevalence of chronic and infectious diseases is boosting demand for early and accurate diagnostics.
• Collaborations between diagnostics firms and biotech start-ups are accelerating development pipelines.
• Government-led screening programs for HIV, hepatitis, and cancer are expanding immunodiagnostics adoption.
• High-throughput chemiluminescence analyzers are gaining traction in hospital laboratories.
• Personalized medicine is creating a rising demand for precise and targeted diagnostics.
• Due to botulinum toxin's extreme potency, strict quality control mandates the frequent replacement of reagents and consumables.
• Oncology and endocrinology is predicted to hold around 29.5% share in 2025 owing to increasing regulatory approvals for oncology-focused immunodiagnostics and high incidence of endocrine disorders.
• Surging adoption of home testing and decentralized diagnostics post-COVID is sustaining market momentum across North America.

Global Market Attribute	Key Insights
Immunodiagnostics Market Size (2025E)	US$ 23.4 Bn
Market Value Forecast (2032F)	US$ 38.1 Bn
Projected Growth (CAGR 2025 to 2032)	7.2%
Historical Market Growth (CAGR 2019 to 2024)	6.5%

Market Dynamics

Driver - Global Surge in Infectious and Chronic Diseases Boosts Demand

Increasing prevalence of HIV, cancer, hepatitis, and respiratory infections is boosting the immunodiagnostics market growth. These diseases require early and accurate detection, which immunoassays are uniquely positioned to deliver. For example, immunoassays help detect low levels of HIV p24 antigen and HIV-1/2 antibodies during the early stages of infection. Cancer is a key market growth driver. As global cancer cases continue to rise, healthcare providers are turning to immunodiagnostics for tumor marker screening and therapy monitoring.

Hepatitis B and C are also pushing demand, especially in Asia Pacific where prevalence remains high. The World Health Organization’s (WHO) 2025 strategy emphasizes early detection through HBsAg and anti-HCV antibody testing. Vietnam followed this recommendation by launching a national hepatitis B screening campaign in 2024. It deployed more than 500,000 rapid immunoassay kits to test pregnant women within six months.

Restraint - False Positives from Antigen Overlap Pose Barrier

Cross-reactivity with similar antigens is a key challenge in immunodiagnostics, as it can lead to false-positive results and reduce diagnostic accuracy. The issue is hampering growth in regions where multiple pathogens with overlapping antigenic structures are prevalent. For example, in tropical countries, co-circulating viruses such as dengue, Zika, and chikungunya share structural similarities that often confuse antibody-based assays.

Such diagnostic ambiguity is not limited to infectious diseases. In autoimmune and allergy testing, antigens with partial homology can also trigger non-specific antibody binding. A 2025 study published in Clinical Chemistry and Laboratory Medicine revealed that thyroid peroxidase (TPO) antibody assays showed interference in patients with rheumatoid factors. These inaccuracies often delay correct treatment, specifically when immunoassays are used as standalone diagnostics without molecular confirmation.

Opportunity - AlphaLISA Technology Creates New Growth Avenues

The emergence of bead-based AlphaLISA technology is creating new possibilities in immunodiagnostics. It is enabling high-sensitivity and no-wash assays suitable for low-volume and high-throughput testing environments. AlphaLISA or Amplified Luminescent Proximity Homogeneous Assay allows for a single-step workflow with chemiluminescent signal generation. This feature drastically reduces assay time and improves automation compatibility, making it suitable for screening large sample sets.

One of the most significant advantages of AlphaLISA is its capacity to detect analytes at femtogram levels without interference from complex biological matrices. This makes it useful in applications such as autoimmune disease diagnostics, where signal noise often complicates results. AlphaLISA is also well-suited for multiplexing, allowing simultaneous measurement of several biomarkers from a small volume of sample. This is important in infectious disease testing, where multiple immune responses require quick assessment.

Category-wise Analysis

Product Type Insights

In terms of product type, the market is bifurcated into instruments and reagents and consumables. Out of these, reagents and consumables are estimated to hold about 54.2% of the immunodiagnostics market share in 2025 with their recurring use across a wide range of testing applications. This makes them the primary revenue driver for diagnostic companies. Dominance is also bolstered by the proprietary nature of several reagent formulations, which ties customers to specific platforms.

Instruments are gaining momentum because they serve as the technological backbone enabling assay automation, high-throughput processing, and integration with Laboratory Information Systems (LIS). These systems help in executing complex panels, tracking reagent usage, reducing contamination risk, and auto-validating results in real time. Increasing demand for integrated platforms that combine immunoassays with other diagnostic modalities is also pushing instrument sales.

Application Insights

Based on application, the market is divided into infectious diseases, oncology and endocrinology, bone and mineral diseases, autoimmunity disorders, cardiac biomarkers, drug monitoring, and others. Among these, the oncology and endocrinology segment is poised to account for nearly 29.5% of share in 2025 due to the clinical shift toward early detection of cancer biomarkers mainly in asymptomatic or high-risk populations. Immunoassays are ideal for this as they help detect minute concentrations of tumor-associated antigens such as prostate-specific antigen.

Infectious diseases are speculated to see considerable growth owing to the mutation of known pathogens. Additionally, the global rise in antimicrobial resistance and persistent gaps in early-stage detection are anticipated to bolster growth. Investments in immunodiagnostic infrastructure aimed at respiratory viruses, endemic, and emerging infections have increased following the COVID-19 pandemic. The World Health Organization's 2025 priority pathogen list has raised the focus on rapid diagnostics for TB, HIV, malaria, and viral hepatitis.

Regional Insights

North America Immunodiagnostics Market Trends - High-throughput Platforms and Home Testing Expand Growth

In 2025, North America is projected to account for approximately 38.3% of share due to the ongoing shift toward automation, multi-disease panels, and precision-based applications. The U.S. immunodiagnostics market is expected to dominate through 2032 with increasing investment by domestic players in high-throughput chemiluminescence and immunoassay platforms made for hospital labs. In 2024, for example, Abbott received FDA clearance for an upgraded version of its Alinity i immunoassay analyzer. It is capable of processing over 170 tests per hour with integrated quality controls.

There is also a surge in the use of immunodiagnostics in decentralized care models. It is supported by increasing adoption of point-of-care (POC) and home-based diagnostics. Expanded insurance coverage for infectious disease and cardiac marker tests is another prominent factor boosting growth. The U.S. is further experiencing increasing research and development activities in the field of multiplexed testing. Researchers at Emory University, for instance, recently developed a portable paper-based immunoassay capable of simultaneously detecting HIV, syphilis, and hepatitis B from a single finger-prick.

Europe Immunodiagnostics Market Trends - Screening Initiatives and IVDR Compliance Propel Demand

Europe’s market is mainly propelled by a move toward value-based diagnostics, population screening programs, and region-specific disease detection. Germany, France, and the U.K. are emphasizing early diagnosis of chronic and infectious diseases through nationwide screening initiatives. The U.K. National Health Service (NHS), for example, recently expanded its use of immunoassays for early cancer detection and cardiovascular biomarkers under its Genomic Medicine Service. It utilizes novel protein-based assays in routine screening.

Regulatory harmonization across the EU under the In Vitro Diagnostic Regulation (IVDR) has also changed the commercial landscape. Companies must now present powerful clinical evidence for their immunoassay kits, leading to the withdrawal of several CE-marked legacy tests. Hence, companies such as Siemens Healthineers and DiaSorin are launching IVDR-compliant assays. Poland and Romania are experiencing steady growth due to increased public health investments post-COVID.

Asia Pacific Immunodiagnostics Market Trends - Ayushman Bharat and PLI Scheme to Strengthen India’s Role

In Asia Pacific, the market is witnessing considerable growth augmented by increasing public health initiatives, rising non-communicable disease prevalence, and local manufacturing capacity expansion. China remains at the forefront, with companies such as Mindray and Snibe launching Chemiluminescence Immunoassay (CLIA) analyzers across secondary and tertiary hospitals. In early 2025, for example, Snibe introduced its MAGLUMI X9 platform, a high-throughput, fully automated CLIA system capable of processing up to 720 tests per hour.

India is emerging as a prominent hub for both production and consumption. The National Health Authority's rollout of diagnostics under Ayushman Bharat is spurring demand for cost-effective immunoassays for hepatitis, tuberculosis, and HIV. In 2024, Agappe Diagnostics collaborated with Japan’s Fujirebio to launch CLEIA platforms catering to labs in India. In addition, local players are benefiting from the government’s Production Linked Incentive (PLI) scheme. It has boosted investment in diagnostic manufacturing parks in states such as Telangana and Gujarat.

Competitive Landscape

The immunodiagnostics market houses several large-scale diagnostic firms and emerging biotech companies, each striving to innovate in terms of assay sensitivity, speed, and automation. Key players are dominating through extensive test portfolios and integrated laboratory platforms. They are also investing huge sums in research and development activities. They are often first to market with high-throughput immunoassay systems that combine immunodiagnostics with AI-based result interpretation. There is increasing activity from mid-sized players and start-ups targeting niche applications such as autoimmune disorders and point-of-care (POC) diagnostics.

Key Industry Developments

• In September 2024, Diasorin launched the new LIAISON S. pneumoniae Antigen Immunodiagnostic Assay in all countries accepting the CE Mark. It would help in the diagnosis of pneumococcal pneumonia infection, a Community-Acquired Pneumonia (CAP).
• In January 2024, Fujirebio Holdings, Inc. and Agappe Diagnostics Ltd entered into an agreement of Contract Development and Manufacturing Organization (CDMO) collaboration. It was aimed at Cartridge-based CLIA system reagents manufacturing project for the immunology equipment Mispa i60 and Mispa i121.

Companies Covered in Immunodiagnostics Market

• Abbott
• Roche Diagnostics
• DiaSorin
• Danaher Corporation
• QIAGEN
• bioMérieux
• Thermo Fisher Scientific
• Quest Diagnostics
• Siemens Healthineers AG
• Bio-Rad Laboratories, Inc.
• Sysmex Corporation
• PerkinElmer, Inc.
• Agilent Technologies, Inc.
• Mindray Medical International Limited
• Grifols, S.A.
• Becton, Dickinson and Company (BD)
• Abcam plc
• Merck KGaA
• Enzo Biochem, Inc.
• Bio-Techne Corporation
• Meso Scale Diagnostics, LLC.
• GenScript Biotech Corporation
• Myriad Genetics, Inc.
• Others